Manager Regulatory Affairs (CMC)

Who we are.

Dendreon is making the battle against cancer personal. Our flagship product PROVENGE^® (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells.

If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beach, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.

Core Values:

• Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer
• Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.
• Build Trust. Building trust takes time. Engage teammates, be candid and transparent. Over communicate and seek feedback.
• Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
• Drive Results. Be accountable and execute – we win together when everyone performs

Your Role:  The Manager, Regulatory Affairs (CMC) is responsible for providing regulatory support and guidance on CMC -related submissions to the FDA and other regulatory authorities worldwide. You will assist in the development and execution of CMC regulatory strategies, regulatory submissions (IND, BLA, NDA) in the area of Human Gene and Cell Therapies and/or other biologics. 

Your Work:

• Provides CMC regulatory support and guidance to project teams for clinical development and post approval changes; defines CMC regulatory submission strategies during development and post approval.
• Experienced with clinical trial (IND/IMPD/CTA) and marketing applications (BLA/NDA/MAA) filing requirements including content requirement, technical writing, and tracking timelines.
• Works with technical departments in R&D/Operations/Quality to develop high quality submissions.
• Prepares and manages submissions to filings and supports review by regulatory authorities.
• Liaises with FDA and other regulatory authorities in written communication and participates in meetings on product development regulatory issues.
• Stays current with regulations and regulatory guidance documents.
• Responsibilities include preparing regulatory assessments of manufacturing changes, authoring department SOPs, etc.
• Prepares and/or reviews labeling, biological product deviation reporting, lot distribution reports, IND safety reports, clinical/investigator documentation, or other reports, as needed.
• Other duties as required.
• May or may not manage direct reports.

Education Requirements:

• Bachelor’s degree in a scientific discipline or equivalent

Job Requirements:

• Typically 7 years of related experience in FDA regulated industry
• At least 3 years of experience in CMC regulatory affairs
• Experience with biologics required, cellular therapy experience strongly preferred
• Experience with eCTD – electronic documents and submissions
• Knowledge of cGMP/ICH/FDA regulations.

Working Conditions and Physical Requirements:

• Ability to sit or stand for extended periods of time 
• Intermittent walking to gain access to work areas
• Finger dexterity sufficient to use a computer and to complete paperwork activities
• Vision sufficient to use a computer, to read written materials and to complete paperwork activities;
• Hearing sufficient to communicate with individuals by telephone and in person
• Ability to lift up to 25 pounds. Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC); (-196ºC) areas.
• Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.
• May be required to work alternate shifts
• Ability to gown aseptically for work in Clean Room environments
• Job performed in a lab, office, or utility (noisy) environment
• Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.